HIV activists and senior doctors have called for an urgent investigation into the continued rollout of a controversial male circumcision device in KwaZulu-Natal.
The demand comes after the Treatment Action Campaign came into possession of evidence that included disturbing graphic images of injuries circumcised men contracted, allegedly after using the TaraKLamp, a device which is being rolled out in the province with the tacit support of the provincial government and the Zulu king Goodwill Zwelethini.
According to media reports last year, the Zulu king was given a car by those who are selling the TaraKLamp.
These reports and other have also been published on Quackdown, a website which aims to expose people and companies who sell untested health remedies.
The TAC was handed a study apparently being used by the KwaZulu-Natal government that compares the TaraKLamp to the Forceps Guided Method which is used in the rest of the country.
Researchers claimed that there was no real difference between the two, but it has since emerged that the study was illegal, as the researchers had no ethical clearance to conduct it.
TAC Treasurer Nathan Geffen said that in a meeting with KwaZulu-Natal Premier, Zweli Mkhize and his officials, "it became clear that the KZN government was intent on rolling out this device even though it has been shown to be unsafe in a clinical trial".
Geffen said the study proved that the province was prepared to proceed with "ethically dubious" research.
"The Premier knew this, yet he allowed the situation to continue. He must take responsibility for this disgraceful situation and an urgent commission of enquiry into the actions of the KwaZulu-Natal government is needed with the use of the TaraKLamp ended immediately," said Geffen.
Several attempts to get a response from Mkhize's office failed.
The TaraKLamp works by clamping shut on the foreskin so that the blood supply to it is cut off. Over a period of 7 to 10 days the foreskin is supposed to die and fall off with the clamp, but sometimes the clamp must be surgically removed.
There is concern that the illegal study is being used to justify the rollout of the TaraKLamp, which has been dogged by controversy including claims of corruption.
Principal investigator of the controversial study, Dr Irwin Friedman confirmed that the report "did not provide any robust evidence in favour of the TaraKLamp and may not legitimately be used for this purpose". He said the report was only for internal use.
He conceded that a serious strategic error was made in reviewing data before final ethics approval had been given.
One of the Co-Principal investigators, the Health Systems Trust, withdrew from the study once it emerged that ethical permission had not been obtained.
"Even it was only intended for internal distribution, the report is so inept it would make an undergraduate blush. That someone was paid for this, and over such an important topic, is astonishing. I can only hope that no one in the KZN health department took this nonsense seriously," said Professor Francois Venter, Deputy Executive Director of the Wits Reproductive Health and HIV Institute.
Sandile Tshabalala, Programme Manager for Medical Male Circumcision in the province, confirmed that they had already circumcised over 18 000 men using the TaraKLamp, claiming that the adverse events were low.
He further confirmed "information gathered on the Tara KLamp in 2010 (when the study was done) convinced the KZN government that it was safe, cheap and quick to use".
Tshabalala was at pains to point out that adverse events were due to the "skill of the human" rather that the device.
He failed to comment on the lack of ethical permission to conduct the review, but rather said it had been approved by "the department internally".
Dr Francesca Conradie, President of the Southern African HIV Clinicians Society warned that great care should be taken not to undermine the national medical male circumcision campaign.
She questioned the use of the Tara KLamp in KwaZulu-Natal "when there is no evidence of its safety in a properly conducted randomised clinical trial.
Conradie joined Geffen in demanding an enquiry "into what appears to be a gross violation of human rights".
The only randomised clinical trial of the Tara KLamp involving adults was conducted in Orange Farm, comparing it to the standard forceps guided method.
The trial was ended early because the adverse event rate in the KLamp arm was about 37% versus about 2% for the standard method. Men also reported intense pain from the KLamp.
The KLamp is also more expensive than the forceps guided method.
* The graphic images can be viewed at www.quackdown.info